Decision Systems · Medical Device & Pharmaceutical Quality

Be paranoid about quality.
Be precise about action.

Most teams document decisions. Very few control them. ParanoiaIQ™ is the decision layer your QMS is missing — ensuring every quality event is evaluated consistently, defensibly, before it becomes a regulatory event.

See How It Works View Services
65%
of Class I recalls are design failures — risk built in from the start
30mo
median time from distribution to recall — the signal existed long before the action
66%
of recalled devices had a prior recall — the same decision failures repeat
Source: Mooghali M et al., "Characterization of FDA Class I Recalls," Medical Devices: Evidence and Research, 2023. PMID 37229515. n=189 Class I recalls, 2018–2022.

"Most organizations don't miss risk because they lack data. They miss it because no system forces the right decision at the right time." — Matt Collins, Founder · ParanoiaIQ™

How It Works

Five decision engines. One system. Every quality event handled the same way.

Each engine is a structured, step-by-step decision framework for a specific regulatory problem — built from primary sources, calibrated against 189 Class I recalls, and traceable to every claim.

Engine 01
CAPA Engine
Is this corrective action investigation rigorous enough to survive FDA scrutiny? Problem definition scored before RCA begins.
Engine 02
HHE Engine
How serious is this patient safety risk — and what recall class does that imply? P × S matrix with probability override rule.
Engine 03
Field Action Engine
Is this a recall, market withdrawal, or nothing? What does 21 CFR Part 806 require? Decision in hours, not days.
Engine 04
Regulatory Decision Engine
What regulations apply to this device in this market? What's the pathway? Covers FDA, EU MDR, ISO 13485.
Engine 05
Risk File Engine
Does our ISO 14971 risk management file meet the standard? Where are the gaps before the auditor finds them?
Human Gate
Every output reviewed, signed, and timestamped before any action proceeds. AI structures. You approve.
Standard Path — Every Event
01 · Event Intake
Single intake point
Complaint · Deviation · Nonconformance · Field Report
02 · Decision
CAPA Escalation Gate
Three criteria. No criterion met: event closed. No CAPA opened.
03 · CAPA Engine
Problem in Focus
Precision problem definition before RCA. Right-sized routing. Effectiveness criteria set at opening.
04 · Human Gate
AI structures. Human approves.
Reviewed, signed, timestamped, audit-ready before any action proceeds.
The Ecosystem in Action

One complaint. Two engines.
One documented decision.

Based on a real Class I recall — angiographic rotating adaptor syringe, March 2026. Four serious injuries reported before recall initiation. Device class: cardiovascular. Distribution: national.

1
Event Intake
Field complaint logged: rotating adaptor loosening under torsional load during cardiac catheterization. Cross-referenced against device risk file. FMEA probability rated Rare — field rate does not match.
Field rate exceeds documented FMEA parameters. CAPA Gate evaluation begins.
2
CAPA Gate — Frequency Trigger Fires
Severity: no confirmed patient harm — not triggered. Management: no regulatory flag — not triggered. Frequency: complaint rate now exceeds documented FMEA threshold across distributed units.
Frequency trigger fires. CAPA opened. Problem in Focus begins.
3
CAPA Engine — Problem in Focus
Problem scoped precisely: rotating adaptor connection loosening under torsional load during high-pressure injection in cardiac catheterization procedures, at a field complaint rate exceeding the documented FMEA probability threshold across affected lot numbers. Not "syringe failure." Not "loose adaptor."
CAPA risk assessment identifies patient safety exposure. HHE Engine activated.
4
HHE Engine — Risk Level: High
Probability: Occasional — rate exceeds FMEA threshold. Severity: Catastrophic — air embolism or blood loss during interventional cardiac procedure. Probability Override Rule applies: life-sustaining device with clear pathway to serious injury.
Class I determination. Field Action Engine activated.
5
Field Action Engine — Urgent Voluntary Recall
Life-sustaining device confirmed. All distributed units carry the potential failure mode. Market withdrawal insufficient — risk profile requires full recall. Scope: all affected lot numbers.
Recommendation: Urgent voluntary recall.
6
Human Gate — Decision Documented
Quality professional reviews CAPA packet and field action recommendation in one session. Each with full rationale and regulatory citations. Decision documented, timestamped, and audit-ready before the next morning.
One event. Two engines. One auditable decision packet.
"Opening the CAPA was correct. The failure was in how risk was evaluated and acted on inside it. On a cardiovascular device with a known high-severity failure mode and rising complaint rates, the actions taken were not commensurate with risk. When effectiveness failed and complaint rates exceeded thresholds, the system did not escalate. It closed the CAPA and opened another. That is the gap: not detection, but failure to act on signal."
Matt Collins, ParanoiaIQ™
Source: FDA Warning Letter 723866 · Medline Industries LP · March 25, 2026 · 21 CFR 820.100
Services

Four engagements. One framework. Every regulatory situation covered.

Start with the diagnostic. No budget approval risk. Immediate deliverable. If you have an inspection in 90 days, start today.

Level 1 · Entry Point
IQx Diagnostic
From $20K · 1 week
  • Structured assessment against 21 CFR 820.100, ISO 13485, CP 7382.850
  • Gap report across CAPA, QMS, risk file, regulatory
  • Findings readout and recommended path forward
  • Recommends the right sprint engagement
Start with Diagnostic
Level 2 · Most Common
Problem in Focus Sprint
From $40K · 2–4 weeks
  • CAPAs close faster because the problem is defined precisely — not broadly
  • Repeat rate drops — same root cause stops appearing in different CAPA numbers
  • Scope is controlled from day one — no more boiling the ocean
  • Routing framework in your SOP — Fast-Track vs. External criteria, documented
  • Effectiveness check playbook — Types 1–4, auditor-ready rationale
  • Backlog triage — closeable vs. escalation, actioned
  • Optional: AI CAPA Engine deployed in your eQMS
Get Started
Level 3 · Ongoing
Retainer
From $10K/month · 6-month minimum
  • All five engines — continuous access
  • Management review support
  • Inspection preparation
  • Ongoing CAPA and field action advisory
  • Priority response within 4 hours
Discuss Retainer
Level 4 · Emergency
FDA Response Sprint
From $75K · 2–3 weeks
  • 483 observation response — structured, specific, submitted on time
  • Warning Letter CAPA plan — root cause addressed with commitments you can actually keep
  • AI Notice response — demonstrate human oversight architecture to FDA's stated concern
  • Every commitment tied to a real corrective action, not a timeline placeholder
  • Built on the Problem in Focus framework — so the fix holds
Contact Matt
Why ParanoiaIQ
The methodology is proven, not theoretical.

MDIC pilot across eight major device manufacturers: 65% cycle time reduction, 0.4% repeat rate, zero audit findings across 32 audits. The framework was built inside real QMS environments, not a consulting slide deck.

You get the capability, not just the deliverable.

Every engagement leaves your team with tools they can run: trained on the method, SOP updated, decision logic documented. The next CAPA does not require another consultant.

25 years of regulatory situations, not just QMS theory.

Warning Letter remediation, consent decree compliance, Class I recall management, FDA inspection prep. The decisions you are facing have been navigated before, at companies with the same constraints yours has.

Fixed scope. No billable-hour expansion.

Every engagement is scoped and priced upfront. You know what you are getting, what it costs, and when it ends. No discovery phases that become projects. No scope creep disguised as thoroughness.

The ROI case: A single FDA Warning Letter costs $500K–$2M+ in remediation, lost production, and consultant fees. The Problem in Focus Sprint costs $40–75K and leaves your team with the skill, the SOP, and the precision to prevent the next one.

The Founder

Matt Collins

I built ParanoiaIQ™ because I kept seeing the same failure modes across every company I worked in: risk files that hadn't been updated since clearance, CAPAs that closed without fixing the root cause, and escalation decisions that varied by reviewer on the same event.

After 25 years inside these decisions — Warning Letter remediation, consent decree compliance, Class I recall management — I knew the pattern well enough to build a system around it.

The methodology behind ParanoiaIQ™ is backed by MDIC pilot data across eight major device manufacturers: 65% cycle time reduction · 0.4% repeat rate · zero audit findings across 32 audits.

This is not theory. It runs on data I helped generate.

Regulatory Situations Navigated
  • FDA Warning Letter remediation
  • Consent decree compliance
  • 483 observation response and closure
  • FDA inspection readiness
  • Class I, II, and III recall management
  • MDSAP multi-site certification
  • EU MDR market access
  • Post-market surveillance program build
  • Quality system scale-up through M&A
  • Pharmaceutical CGMP remediation (21 CFR 210/211)
  • Combination product and biologics quality
  • GDP and cold chain compliance
Resources

Free tools and guides for VP-level Quality leaders.

Built from the same methodology powering the engines. Download free. No sales call required.

Checklist · PDF
CAPA Problem Definition Checklist
The 12-point checklist used to score problem statements before RCA begins. If your problem statement can't pass this, the CAPA will fail FDA scrutiny.
Free download · email required
Download Free
Decision Guide · PDF
Is This a Recall? The Field Action Decision Guide
A step-by-step decision tree for the question that keeps Quality VPs up at night. Covers 21 CFR Part 806, recall vs. market withdrawal vs. no action, and when to call FDA first.
Free download · email required
Download Free
Analysis · Article
FDA's AI Warning Letter: What It Means for Your QMS
In April 2026, FDA issued its first Warning Letter citing AI overreliance. This analysis breaks down what it requires, what "human review" means under 21 CFR 211.22(c), and how to comply by design.
Free · no email required
Read Now
Get Started

The recall you prevent is the one nobody hears about.

Walk your last quality event through the engine. We will show you exactly where the decision would have changed. 20 minutes. No integration required.

mcollins@paranoiaiq.com LinkedIn — Matt Collins Response within 24 hours

Or email directly: mcollins@paranoiaiq.com